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FDA declines emergency use approval for Humanigen's COVID-19 drug

Christian Fernsby ▼ |
Humanigen announced the U.S. FDA has declined its request for emergency use authorization of lenzilumab to treat newly hospitalized COVID-19 patients.

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In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19.

“We remain committed to bringing lenzilumab to patients hospitalized with COVID-19,” said Cameron Durrant, MD, Chief Executive Officer, Humanigen.

“We believe the ongoing ACTIV-5/BET-B trial, which has been advanced to enroll up to 500 patients, may provide additional safety and efficacy data sufficient to support our efforts to obtain an EUA to treat hospitalized COVID-19 patients.” ■

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